Senior Regulatory Affairs Project Leader
A Dynamic Senior Regulatory Affairs Project Leader with over 30 plus years of experience in regulatory affairs, Quality control and Quality Assurance, R&D, technical services in Active Pharmaceutical Ingredients (API) and Drug Products. Proven track record of preparing Drug Master Files and Drug Product submissions and registrations, while ensuring the compliance with global Heath Authorities. Successfully developed regulatory strategies leading to streamlined approvals.
With expertise in project management and technical assessments, poised to drive regulatory excellence and innovation in the industry, contributing significantly to organizational success.
Senior Regulatory Affairs Project Leader - Apotex Pharmachem Inc. - Brantford, ON, Canada
(2007-10)
General Manager- Regulatory Affairs - USV Limited - Mumbai, India
(2005-11 - 2006-06)
Dy. General Manager- Regulatory Affairs - Unichem Laboratories Limited - Mumbai, India
(1999-08 - 2005-10)
Senior Manager- Technical Services & Regulatory Affairs - IPCA Laboratories Limited, International Division - Mumbai, India
(1996-10 - 1999-08)
Manager- Drug Regulatory Affairs - Ranbaxy Laboratories Limited - New Delhi, India
(1994-01 - 1996-10)
QA & Analytical Development Executive - Kopran Limited - Mumbai, India
(1992-01 - 1994-01)
Senior QA & QC officer - Cophar Laboratories Limited - Mumbai, India
(1989-11 - 1992-01)
Doctor of Philosophy - Analytical Chemistry - University of Mumbai (Bombay)
